Enanta Pharmaceuticals, Inc., a clinical-stage biotechnology company, announced positive topline data from a phase 1 study assessing the safety, tolerability, and pharmacokinetics (PK) of orally administered single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-235 in healthy adult subjects.
EDP-235, a coronavirus 3CL protease inhibitor, which received Fast Track designation from the US Food and Drug Administration (FDA), is specifically designed to be a once-daily, oral antiviral treatment for Covid-19. Data from the phase 1 study demonstrated favorable safety, tolerability, and PK with strong exposure multiples over the EC90, thereby supporting the advancement of EDP-235 into a phase 2 study using once-daily dosing, without ritonavir.
